FDA 510(k) Application Details - K043361

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K043361
Device Name	Electrode, Electrocardiograph
Applicant	ADVANCED BIOELECTRIC CORPORATION 2160 JOHNSON STREET SAINT-LAURENT, QUEBEC H4M 1M1 CA Other 510(k) Applications for this Company
Contact	MARC-ANDRE COTE Other 510(k) Applications for this Contact
Regulation Number	870.2360   More FDA Info for this Regulation Number
Classification Product Code	DRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2004
Decision Date	03/22/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review